BEUDAMED
    17 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-00-10, 60-00-55

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065722·INTRAORAL ELASTICS 4,5 oz 3/8" orange

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310080·Probe, 1.5 inch Ball, Lenke, Thoracic, Straight...

    COALESCE

    FDA UDI
    VERTERA, INC.·B1422000000910080·9x23x10MM COALESCE-Straight, Lordotic

    Orthopedic Instruments

    FDA UDI
    GM DOS REIS INDUSTRIA E COMERCIO LTDA·07899258660721·

    CoolSmooth PRO Card

    FDA UDI
    Zeltiq Aesthetics, Inc.·00816417020476·CoolSmooth PRO Card 8 Cycle

    WAVEWRITER ALPHA PRIME 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·March 12, 2025

    ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROI-C IMPLANT, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MÉDICAL·Product code OVE·August 24, 2021

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 2, 2013

    ASR ACETABULAR CUPS 50

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KWA·September 16, 2014

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·May 3, 2011

    SPACER, UNKNOWN SIZE

    FDA Adverse Event
    Injury ·LDR MEDICAL·Product code ODP·August 23, 2019

    INTELLIS

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·August 24, 2023

    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code CAD·November 18, 2024

    Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610-000, 1107-9612-000, 1107-9616-000, 1107-9617-000, 2066835-001, 2069767-001, 2078800-001, 2091008-001, 2091009-001, M1098876, M1145610, M1220023, M1220854, M1221495, and M1233992

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·January 15, 2025